MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA RIST; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	106F-071-95
Medical Device Problem Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis ¿equipment used: video inspection system (m-81805), 203cm ruler (m-83360) ¿as found condition: the rist catheter was returned for analysis inside a sealed biohazard plastic pouch and inside a shipping box.The original packaging and shipping box were not returned.¿damaged location details: the rist catheter tip and marker were examined, and no damage was noted.The catheter was observed to be broken at ~3.8cm from the proximal end of the catheter hub and kinked at ~5.5cm from the proximal end of the catheter hub.No voids or flashes were found in the catheter hub.No other anomalies were found ¿testing/analysis: the catheter was flushed with water, and water exited through the broken section of the catheter.¿conclusion: based on the reported information and device analysis, the customer¿s ¿catheter kink/damage¿ report was confirmed, as the returned rist catheter was observed to be broken and kinked.Damage can occur due to impact from an unknown source prior to opening, damage during storage, user-related, or manufacturing-related (e.G., operator handling, missed inspection).However, the cause could not be determined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that a rist catheter was damaged out of packaging.A kink was observed.No patient complications were associated with this event.Additional information received reported that the damage was on the packaged introducer guide.The cause of the event was determined to be kinked upon delivery.All information had been confirmed/provided by the physician.Additional information received.Facility name and address was provided.

• Brand Name: RIST
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine,ca
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine,ca
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 25257696
• Report Number: 2029214-2026-00946
• Device Sequence Number: 12136432
• Product Code: QJP
• UDI-Device Identifier: 00763000541194
• UDI-Public: (01)00763000541194(17)280812(10)28043-01
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 106F-071-95
• Device Catalogue Number: 106F-071-95
• Device Lot Number: 28043-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown